Kornimate/medical-research-clean huggingface dataset:
phase iii trial to investigate efficacy and safety of vilobelimab in ulcerative pyoderma gangrenosum

Conditions: Pyoderma Gangrenosum

Summary: a randomized, double-blind, placebo-controlled, multicenter, adaptive phase iii trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum


Eligibility criteria:
main inclusion criteria: 1. 18 years or older at the time of signing the informed consent. 2. investigator confirmed clinical diagnosis of ulcerative pg. diagnosis shall be supported by clinical assessment of pg symptoms via paracelsus score (jockenhofer, wollina et al. 2019) of 10 points or more (see appendix - section 12.1). note: in case of paracelsus score \< 10, additional justification shall be provided by the investigator to support clinical diagnosis of ulcerative pg. 3. minimum of 1 evaluable pg ulcer (other than peristomal) which qualifies as the target ulcer by meeting the following criteria (orfaly, reese et al. 2022): area of ≥ 5 cm 2 at screening and baseline * circulated by intact skin * evaluable by at least 2-dimensional measurement main exclusion criteria: 1. patients with target ulcers exceeding 80 cm 2 . 2. patients with target ulcer in transplanted skin. 3. surgical wound debridement or negative pressure wound therapy (npwt) for the target ulcer within 4 weeks before baseline (i.e., start of treatment with imp). 4. patient with previous exposure to vilobelimab (ifx-1) prior to baseline (i.e., start of treatment with imp). 5. patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start of treatment with imp). 6. any active infection requiring systemic antibiotic or other systemic treatment or suppressive anti-infective therapy within 2 weeks prior to baseline (i.e., start of treatment with imp). 7. patients received any systemic medical treatment for pg within 4 weeks prior to baseline 8. patients received any biological or immunomodulatory therapy for pg within 4 weeks prior to baseline (i.e., start of treatment with imp), except existing biologic or immunomodulatory therapy used for an underlying disease (other than pg at a stable therapy with no dose adjustments for at least two maintenance doses prior to screening this is allowed to be continued. 9. patients receiving corticosteroids treatment for pg of more than 10 mg/day of prednisone or equivalent within 4 weeks prior to baseline (i.e., start of treatment with imp).
effect of shockwave versus lll therapy on sacroiliac joint pain in postnatal women

Conditions: Sacroiliac Joint Pain

Summary: sacroiliac joint pain is the most causes of back pain in pregnancy caused ligament laxity in sacroiliac joint so cause pain and this pain continue after natal shock wave is new conservative treatment used in physical therapy shock wave is most effective for sacroiliac joint pain low level laser is a most effective pain relive and effective on sacroiliac joint pain

the study is to determine if there is any difference between the effect of shockwave and low level laser therapy on sacroiliac joint pain in postnatal women this study will be randomly distributed into two equal group group a consisted of 25 postpartum women complaining from sacroiliac joint pain . they will receive shockwave therapy 2 session per week for 6 weeks group b consisted of 25 postpartum women complaining from sacroiliac joint pain . they will receive low level laser therapy 2 session per week for 6 weeks evaluation procedures history taking recording in recording data sheet weight and height measurement by calculate bmi disability assessment by owdi pain assessment by vas scale assessment of pressure of pain threshold by pressure algometry

Eligibility criteria:
inclusion criteria: * postnatal women suffering from sacroiliac joint pain for at least 3 months. * they should have moderate to severe pain . * they should have positive findings in at least 3 of 5 provocation sacroiliac joint tests exclusion criteria: * lumber or hip joint pathology * acute pelvic bacterial or viral infection . * receiving corticosteroid injections within the previous 6 weeks
diabetes in relation to hospitalized covid-19 patents at assiut university hospital

Conditions: Diabetes Mellitus; COVID-19

Summary: coronavirus disease (covid-19), a global pandemic affecting the whole world and taking the lives of millions. the majority of fatalities occur in the elderly specially in the presence of chronic diseases such as diabetes mellitus (dm), hypertension, obesity, cardiovascular disease, chronic kidney disease and cancer.

knowing about the family of coronaviruses is that they are the cause of a variety of well-known diseases affecting humans, ranging from common cold to the middle east respiratory syndrome (mers) and acute severe respiratory syndrome (sars), and now the covid-19 as a new problematic family member. regarding dm as a knowing old health problem, it has been found that we can use it in predicting the prognosis of the covid-19 as admission to intensive care unit, invasive ventilation or even death. previous studies confirmed that uncontrolled dm can badly affects innate immunity which considered as the first line of defence mechanism against covid-19 infection. in addition, dm has a pro-inflammatory effect through exaggeration of cytokine response which appears clearly through higher results of serum levels of interleukin-6 (il-6), c-reactive protein and ferritin, this suggests that people with dm are more venerable to cytokine storm which leads to acute respiratory distress syndrome (ards), shock and rapid deterioration of the case. on the other hand, on looking to previous studies and data collected about the prior sars outbreak in 2003, which suggested that covid-19 can lead to worsening of glycemic control in known diabetic patients and above that caused by the stressful nature of a critical illness. in addition, covid-19 can lead to increasing insulin resistance specially in patients with type ii dm. also, the medications used in the management of covid-19 having an indirect role on worsening of blood sugar levels also should be taken in our consideration, corticosteroids as an example, used in the management of patients having ards or sepsis can lead to changes in their glycemic profile.

Eligibility criteria:
inclusion criteria: * cases aged 18 years and over. * cases diagnosed as covid-19 positive. * cases admitted to assiut university hospitals. exclusion criteria: * age less than 18 years. * outpatient management (even in confirmed cases of covid-19).
mapt haploid h1b and the damage of bbb in dorsal medulla oblongata and autonomic dysfunction in pd

Conditions: Parkinson's Disease

Summary: this study mainly explored the relationship between the permeability of the blood-brain barrier in the dorsal medulla oblongata and autonomic dysfunction, and the relationship and mechanism of mapt genotype on the permeability of the blood-brain barrier and the progression of autonomic dysfunction in pd patients.

according to the mds 2015 clinical diagnostic criteria for parkinson's disease and the diagnostic criteria for autonomic dysfunction (autd), the patients were divided into pd with autd group and pd without autd group. dce results, pet-pdrp+18f-dopa data and clinical evaluation (scopa-aut, hrv and sleep eeg) were analyzed; blood samples were collected to detect mapt gene polymorphism, oligomers and phosphorylated synuclein. to explore the relationship between the permeability of the blood-brain barrier in the dorsal medulla oblongata and autonomic dysfunction, and the relationship and mechanism of mapt genotype on the permeability of the blood-brain barrier and the progression of autonomic dysfunction in pd patients.

Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for idiopathic pd of mds 2015 * age ≥ 45 years old * be able to complete various clinical evaluations and scales; willing to participate in mri, no contrast agent allergy exclusion criteria: * dementia was diagnosed before or 1 year after the onset of motor symptoms * single gene form of pd * coexisting neuropathological diagnosis considered to affect pd progression * known complications affecting bbb (severe infection, cerebral infarction, etc. * such as comorbidities known to affect the autonomic nervous system (e.g., diabetes gangliopathy or neuropathy) * disturbance of consciousness, serious cerebral hemorrhage or cerebral thrombosis, serious brain tumor or brain surgery history, serious mental illness or other serious nervous system diseases, which are enough to seriously interfere with the subjects' motor and non motor symptoms * according to the judgment of the researcher, the researcher is unable to complete the research test according to the requirements of the research scheme.

Keywords: parkinson's disease mapt genotype autonomic dysfunction blood brain barrier
a translational study to describe clinical characteristics, biomarkers and to identify phenotypes and endotypes associated with differential outcomes in chinese population

Conditions: Asthma

Summary: a translational study to describe asthma patient clinical characteristics, treatment patterns, biomarkers and to identify phenotypes and endotypes associated with differential outcomes that may support future development of personalised treatment strategies in chinese population


Eligibility criteria:
inclusion criteria: * age 18 to 75 years of age * acceptable fev1 (according to ats and ers) * compliance with study procedures all asthma cohorts * physician diagnosed asthma greater or equal to 3 months prior to screening visit exclusion criteria: * history of alcohol or drug abuse within the past year * pregnant at time of an assessment * has an altered mental status at the time of informed consent * receipt marketed or investigational biologic(s) within 3 months or 5 half-lives prior to visit 1, whichever is longer * history or current upper or lower respiratory infection or symptoms within 2 weeks of baseline assessments * terminal diseases and/or organ failure or participants otherwise considered not appropriate for the study participation * receipt ltras or 5-lipoxygenase (5-lo) inhibitors (eg zileuton and montelukast) within 1 month or 5 half-lives prior to baseline, whichever is longer.
minrin® orally disintegrating tablet (fast dissolving desmopressin) and tablets in treatment of primary nocturnal enuresis

Conditions: Nocturnal Enuresis

Summary: desmopressin in treatment of nocturnal enuresis (bedwetting).


Eligibility criteria:
inclusion criteria: * treatment of primary nocturnal enuresis within an overall therapeutical concept, eg, in cases of failure of other non-medicinal therapies or with indication of a medicinal therapy caused by nocturnal adh deficiency * the patients and their parents have been informed about the study and have given their written consent for participation. exclusion criteria: * the prescription of minirin® tablets / minirin® orally disintegrating tablet (fast dissolving desmopressin) is contraindicated
mulligan and mckenzie exercises alongwith stabilization exercises in patients with chronic neck pain

Conditions: Neck Pain

Summary: the goal of this \[type of study: randomized control trial\] is to \[ compare the effectiveness of mulligan and mckenzie exercises along with stabilization exercises on pain, range of motion and disability \] in \[ in patients with chronic neck pain\].the main question it aims to answer is: * wether mulligan is more effective or mckenzie exercises along with stabilization exercises in the treatment of patients with chronic neck pain group 1 will recieve mulligan and stabilization exercises group 2 will recieve mckenzie and stabilization exercises

chronic neck pain is a prevalent and multifaceted condition, affecting a substantial portion of the general population (16.7% to 75.1%). different techniques have been used to treat chronic neck pain. in this study, i will be comparing two manual therapy techniques along with stabilization exercises and will check which manual technique with stabilization exercise is more effective in the treatment of chronic neck pain. one of the techniques is mulligan technique. the other one is the self-treatment approach of the mckenzie technique, . additionally, cervical stabilization exercises, incorporating progressive stages, aim to enhance neuromuscular control. the research involves two intervention groups (group a and group b) receiving specific treatments over 32 sessions within an eight-week period. group a incorporates the mulligan technique, cervical and scapulothoracic stabilization exercises, and transcutaneous electrical nerve stimulation (tens) with a heating pad. group b undergoes hot packs and tens, followed by mckenzie exercises and cervical and scapulothoracic stabilization exercises. outcomes, encompassing pain levels, range of motion (rom), and neck disability index (ndi) scores, will be evaluated using the numeric pain rating scale, goniometer, and neck disability scale. data analysis will employ spss version 26. data will be collected at baseline, immediately post-intervention, and at follow-up intervals.

Eligibility criteria:
inclusion criteria: * age 40-65 localized chronic neck pain for more than 3 months exclusion criteria: * participants suffering their neck pain was caused by any other complications.

Keywords: disability, mulligan mobilizations, neck pain, pain
role of sympathetic activation in ischemia reperfusion injury

Conditions: Central Sympathetic Nervous System Diseases

Summary: this study is designed to assess the effect of forearm ischemia-reperfusion injury on sympathetic nerve activity. to determine whether reduced sympathetic responsiveness is a contributor to the protective effects of remote ischemic preconditioning. in addition it will assess whether pharmacologic inhibition of the sympathetic nervous system can ameliorate ischemia reperfusion injury induced endothelial dysfunction.

this is a randomized single blind study where subjects will be allocated to undergo one of the 4 protocols. participants will be given placebo or 0.2mg of moxonidine to take orally 20 minutes prior to the first endothelial function measurement. this medication acts by reducing the activity of nerves believed to be involved in the conditioning process. the placebo pill, designed to have no effect, will be used as a comparison. comprehensive tests will occur which include microneurography, endothelial function ,blood sampling, temporary block of arm blood flow and remote conditioning

Eligibility criteria:
inclusion criteria: * healthy males, not on any medication, free of any history of metabolic, cardiovascular or cerebrovascular disease. exclusion criteria: * smoker

Keywords: ischemia re-perfusion remote conditioning
relative bioavailability and tolerability of two new different extended release capsules of bibv 308 se, versus a solution of bibv 308 se in healthy subjects

Conditions: Healthy

Summary: comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of bibv 308 se following multiple doses.


Eligibility criteria:
inclusion criteria: * subjects that were previously entered in at least one bibv 308 se study to ensure that it is known how these subjects absorb bibv 308 se * healthy subjects as determined by results of screening * signed written informed consent in accordance with good clinical practice (gcp) and local legislation * age \>= 18 and \<= 55 years * broca \>= -20% and \<= +20 % exclusion criteria: * poor individual absorption kinetics of bibv 308 se in previous studies * any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram (ecg)) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorders * surgery of the gastro-intestinal tract (except appendectomy) * diseases of the central nervous system (such as epilepsy) or psychiatric disorders * chronic or acute relevant infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * hypersensitivity to bibv 308 se and any of the excipients * intake of drugs with a long half-life (\> 24 hours) \<= 1 month prior to administration or during the trial * use of any drugs which might influence the results of the trial \<= 10 days prior to administration or during the trial * participation in another trial with an investigational drug \<= 2 months days prior to administration or during the trial * smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * inability to refrain from smoking during the period of the study * known alcohol (\> 60 g/day) or drug abuse * blood donation (\<= 1 month prior to administration) * excessive physical activities (\<= 5 days prior to administration) * any laboratory value outside the normal range of clinical relevance * history of haemorrhagic diathesis * history of gastro-intestinal ulcer, perforation or bleeding * history of bronchial asthma
evaluating ultrasound, elastometry, minilaparoscopy and histology for the diagnosis of compensated liver cirrhosis.

Conditions: Cirrhosis

Summary: prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis.

up to now the gold standard for the diagnosis of liver cirrhosis is to perform liver biopsy. this invasive methode is not undisputed. therefore there is constant effort to improve, develop and apply better diagnostic tools. this study is designed to evaluate the in our eyes now a days most promising examinations: (1) high frequency ultrasound, (2) elastometry and (3) minilaparoscopy. patients for whom the clinical decision to perform mini laparoscopic guided liver biopsy was taken should be recruited. successive at three time points the examiner has to decide for or against cirrhosis: (1) after conventional and high frequency ultrasound (2) after elastometry and (3) after laparoscopy.

Eligibility criteria:
inclusion criteria: * clinical decision to perform minilaparoscopic guided liver biopsy for the staging of liver disease including the assessment of the degree of fibrosis. exclusion criteria: * ascites * decompensated liver disease * esophageal varices * other collateral circulations * obstructive cholestasis * severe heart insufficiency (nyha iii-iv)

Keywords: cirrhosis liver elastometry ultrasound laparoscopy diagnosis
comparison between hugo ras robotic platform and da vinci robotic platform

Conditions: Prostate Cancer (Adenocarcinoma); Renal Cancer

Summary: the study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. it targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (rp) or partial nephrectomy (pn).

the study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. it targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (rp) or partial nephrectomy (pn). the study is divided into a patient enrolment and robot-assisted treatment phase, followed by a phase of oncological and functional follow-up. once enrolled, patients will be randomized to undergo treatment using either the da vinci xi platform (intuitive surgical) or the hugo™ ras platform (medtronic) according to block randomization. patients with prostate cancer (group a), enrolled according to inclusion criteria, will be randomized to undergo rp treatment with the da vinci xi platform (control group) or rp treatment with the hugo™ ras platform (study group). patients with kidney cancer (group b), enrolled according to inclusion criteria, will be randomized to undergo pn treatment with the da vinci xi platform or pn treatment with the hugo™ ras platform. if the surgical, oncological, and functional outcomes observed following radical prostatectomy and partial nephrectomy performed with the hugo ras platform prove to be equivalent to those obtained with the da vinci xi platform, it should lead to a progressive increase in the use of the hugo ras platform, resulting in a reduction in the overall costs associated with robotic urological surgery.

Eligibility criteria:
inclusion criteria: patients with prostate cancer (group a) * age ≥ 18 years. * life expectancy greater than 10 years. * diagnosis of prostate cancer following prostate needle biopsy. * clinical stage ct1-t3b, n0-1 disease. * positive anesthetic fitness assessment for robot-assisted radical prostatectomy. * provision of informed consent for the study. patients with kidney cancer (group b) * age ≥ 18 years. * radiological diagnosis of organ-confined kidney cancer at clinical stage t1a or t1b. * underwent ct and/or mri of the abdomen with contrast medium. * positive anesthetic fitness assessment for robot-assisted partial nephrectomy. * provision of informed consent for the study. exclusion criteria: patients with prostate cancer (group a) * expression of a preference for radical treatment other than surgery (e.g., external radiotherapy). * metastatic prostate cancer (m1). * other conditions deemed by healthcare professionals to contraindicate inclusion in the study. patients with kidney cancer (group b) * indication for radical nephrectomy. * metastatic kidney cancer (m1). * other conditions deemed by healthcare professionals to contraindicate inclusion in the study.